Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE) (NCT04931563) | Clinical Trial Compass
CompletedPhase 3
Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)
China, Hong Kong, Philippines277 participantsStarted 2021-09-13
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in Asian participants with active systemic lupus erythematosus (SLE).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18 to 70 years.
. Body weight ≥ 40 kg.
. Confirmed diagnosis of SLE(1997 ACR revised criteria) for ≥ 24 weeks.
. Must be receiving at least one of the following SOC regimens at screening:
. oral prednisone monotherapy: ≥ 7.5 mg/day and ≤ 40 mg/day, stable for \> 2 weeks;
. Immunosuppressant(s) with or without OCS and must be stable for ≥ 8 weeks;
. Oral prednisone plus immunosuppressant: start date, stability and maximum dose required.
. At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith.
Exclusion criteria
. History or current diagnose of clinically significant non-SLE related vasculitis, severe or unstable neuropsychiatric SLE, active severe SLE-driven renal disease, catastrophic anti-phospholipid syndrome, inflammatory joint or skin disease other than SLE, non-SLE disease that has required treatment of certain dosage of corticosteroid.
. History or evidence of suicidal ideation or suicidal behavior.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This was a Phase 3 trial testing anifrolumab specifically in Asian patients with active lupus — since the trial is now completed, has the data been published, and what did the results show about how well it worked compared to placebo?
2The trial measured how many patients were considered 'responders' — can you explain what that response definition actually means in practical terms, like what symptoms or disease activity had to improve to count?
3Since this study is completed and used a placebo comparison, does the evidence from this trial change whether anifrolumab might be a reasonable option for me, or is standard-of-care treatment still a better first step given my current situation?
4Anifrolumab works by blocking a protein called type I interferon — given my specific lupus history and any other conditions I have, are there particular safety concerns from this trial's findings that you'd want me to know about before considering this type of treatment?
5Because this trial enrolled Asian patients specifically, does that mean its results are more or less applicable to me based on my background, and how does that factor into your recommendation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in Proportion of Participants Who Are Responders Between Anifrolumab and Placebo
. History or current diagnose of MTCD or overlap syndrome, unless overlap with RA or MTCD which has developed into SLE.
. History of recurrent infection requiring hospitalization and IV antibiotics, or opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization, or clinically significant chronic infection within 3 months, or recent infection still under treatment.
. History of immunodeficient condition, HIV positive included.
. Confirmed HBsAg positive, or HBcAb positive and HBV DNA detectable, or hepatitis C antibody positive.
. History of severe case of herpes zoster.
. Herpes zoster, CMV or EB infection which has not completely resolved within 12 weeks before screening.